Exact Classification for Trans Radial Compression Device per EU directive 93/42/EEC

shrutisancheti

shrutisancheti

Starting to get Involved
#1
#1
Dear Friends,
I wish to know the exact classification for Trans radial compression device as per EU directive 93/42/EEC.

Kindly help.

Thank you

Best regards,
 
GAGEpack - Gage & Calibration Management
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dgrainger

dgrainger

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#2
#2
Re: Exact Classification for Trans Radial Compression Device per EU directive 93/42/E

Assuming it's temporary, non-active, sterile, and comes into contact with the wound. Class I under rule 4 might apply. NB needed for sterility issues.
 
S

SteveK

#3
#3
Re: Exact Classification for Trans Radial Compression Device per EU directive 93/42/E

From MEDDEV 2.4.1 Rev 9 it could be a Class 1 under rule 1 i.e.

Devices used to immobilise body parts and/or to apply force or compression
on them (e.g. non-sterile dressings used to aid the healing of a sprain, plaster
of Paris, cervical collars, gravity traction devices, compression hosiery)

Steve
 
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